The Feasibility of a Physical Activity Intervention for Advanced Multiple Myeloma Patients

NCT ID: NCT04303091

Last Updated: 2020-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-02

Study Completion Date

2018-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Although physical activity (PA) is commonly used to manage symptoms and enhance quality of life (QOL) in cancer survivors, relatively little is known regarding the benefits in advanced multiple myeloma (MM). The primary aims of the Physical Activity in Advanced Cancer Treatment (PAACT) intervention were to examine (1) program feasibility and (2) potential impact on patient outcomes. It is hypothesized that an exercise intervention will be feasible and potentially impactful.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

While the introduction of novel and more effective treatments has seen improved survival in multiple myeloma (MM), the aggressive nature of the disease and these corresponding agents can have a debilitating impact on quality of life (QOL). Exercise can help manage symptoms and enhance QOL in cancer survivors, however relatively little is known regarding the feasibility or benefits of exercise in MM. The purpose of this study was to examine the feasibility of a group- and home-based exercise intervention for individuals with advanced MM. In this single arm study, advanced MM patients (DS stage II-III) participated in a 12-week aerobic and resistance training intervention, with the option of palliative care consultation. Participants attended once weekly supervised group exercise classes and received individually tailored home exercise booklets. Validated measures of physical functioning and patient-reported outcomes, including QOL, fatigue, anxiety, depression, and self-compassion were obtained at baseline and 12-weeks (post-intervention). Optional semi-structured interviews were conducted halfway (week 6) and at the end of the intervention (week 12)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma Hematologic Neoplasms Advanced Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group feasibility study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise group

Single-arm study. Participants enrolled engaged in a 12-week exercise program.

Group Type EXPERIMENTAL

Physical Activity for Advanced Cancer Treatment (PAACT)

Intervention Type BEHAVIORAL

12-week physical activity intervention. 60 minute group-based exercise classes held once per week. Home-based exercise recommendations provided weekly along with basic take-home exercise equipment. Optional palliative care consultations offered.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical Activity for Advanced Cancer Treatment (PAACT)

12-week physical activity intervention. 60 minute group-based exercise classes held once per week. Home-based exercise recommendations provided weekly along with basic take-home exercise equipment. Optional palliative care consultations offered.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PAACT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* diagnosed with advanced (Durie-Salmon stage II-III) multiple myeloma
* 18 years of age or older and given a survival prognosis greater than 6 months
* stable hemoglobin level of ≥80g/L as measured within 2 weeks of enrollment
* no active infections at the time of enrollment.

Exclusion Criteria

* refusal of informed consent
* geographically inaccessible
* non-English speaking
* co-morbidities that interfere with participation (i.e., severe mobility issues or cognitive impairments)
* known or active history of substance abuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr. Nicole Culos-Reed

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Nicole Culos-Reed

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nicole r Culos-Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HREBA.CC-17-0058

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Motivational Interviewing for Physical Activity
NCT01008787 ACTIVE_NOT_RECRUITING NA
Part II: Exercise in Hispanic Breast Cancer Survivors
NCT01504789 ACTIVE_NOT_RECRUITING NA